Teva Canada Announces the Launch of Teva-Cyclosporine Ophthalmic Emulsion, the First Generic Version of Restasis in Canada for the Treatment of Dry Eye Disease

Teva Canada Limited, a subsidiary of Teva Pharmaceutical Industries Ltd., announced the launch of Teva-Cyclosporine® ophthalmic emulsion, 0.05% w/v, a Health Canada approved twice-daily eye drop solution and the first generic version of Restasis® (cyclosporine) in Canada.

TORONTO, May 10, 2018 /CNW/ - Teva Canada Limited, a subsidiary of Teva Pharmaceutical Industries Ltd., announced the launch of Teva-Cyclosporine® ophthalmic emulsion, 0.05% w/v, a Health Canada approved twice-daily eye drop solution and the first generic version of Restasis® (cyclosporine) in Canada.

Cyclosporine ophthalmic emulsion is indicated for the treatment of moderate to moderately severei aqueous deficient dry eye disease, characterized by moderate to moderately severe: ocular staining, reduction in tear production and fluctuating visual symptoms, such as blurred vision.

“Dry eye disease negatively impacts a patient’s quality of life and has the potential to cause long-term eye damageii, so it’s crucial patients have access to affordable treatment options made to the highest standards,” said Christine Poulin, Senior Vice President and General Manager, Teva Canada. “With as many as 10 millioniii Canadians potentially suffering from dry eye disease, Teva-Cyclosporine® ophthalmic emulsion will provide relief for the patients’ eyes as well as budget.”

Cyclosporine ophthalmic emulsion (brand: Restasis®) had annual sales of approximately $46.5 million in Canada, based on IQVIA sales data as of March 2018. Teva-Cyclosporine® is available immediately to pharmacies across Canada strengthening the company’s existing ophthalmic portfolio of eight medications, all of which are prescribed to treat and maintain eye health. The launch of Teva-Cyclosporine® demonstrates Teva Canada’s research and development capabilities and desire to continue to support niche patient groups, utilizing specialized technology.

About Dry Eye Disease

Dry Eye Disease is one of the most common conditions encountered in optometric practice with the reported prevalence of this disease being up to 29%iv or over 10 million Canadiansv. Some people are unable to produce enough tears or the appropriate quality of tears to keep their eyes healthy or comfortable. This condition is known as dry eye.vi The common signs and symptoms of dry eye include stinging, gritty, scratchy and uncomfortable eyes, fluctuating vision, and sometimes having a burning feeling or a feeling of something foreign within the eye. Some people experience tearing because of dry eye. This is a natural reflex of the eyes to create more tears to comfort the eye in response to dryness. Dry eye symptoms can result from the normal aging process, hormonal changes, exposure to certain environmental conditions, problems with normal blinking or from medications such as antihistamines, oral contraceptives or antidepressants. Dry eye can also be symptomatic of general health problems, such as arthritis, or can result from UV exposure and environmental irritants.vii Dry eye disease is a growing public health concern causing ocular discomfort, fatigue and visual disturbance that interferes with quality of life, including aspects of physical, social, psychological functioning, daily activities (such as driving, reading, computer use) and workplace productivity.viii

Helping People Live Better Days

At Teva, we help to improve the health of 200 million people every day by providing innovative treatments and access to the world’s largest medicine cabinet of generic and specialty medicines. This gives us a unique perspective on health. Understanding the many ways health impacts people’s lives inspires us to discover new possibilities to bring medicines and more, enabling patients and caregivers to live better days.

About Teva Canada Limited

Teva Canada Limited, headquartered in Toronto, has provided affordable healthcare solutions for 50 years, with sales of more than $1 billion in 2017 and over 249,000 prescriptions filled with our products every dayix. Originally Novopharm Limited, Teva Canada Limited specializes in the development, production and marketing of high-quality generic prescription pharmaceuticals and through our branded division, Teva Canada Innovation, focuses on a diverse line of innovative products in a variety of therapeutic areas. Teva Canada employs more than 1,000 individuals, markets more than 400 productsx in 1,700 SKUs in Canada and is a subsidiary of Teva Pharmaceutical Industries Ltd., the world’s largest generic drug maker. For more information, visit: www.tevacanada.com or www.tevamakesmedicines.ca.

About Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Limited (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2017 were $22.4 billion. For more information, visit www.tevapharm.com.

i Source: Teva-Cyclosporine Product Monograph - Level 2-3 severity by DEWS Guidelines - March 2017

ii Sources: Canadian Association of Optometrists - Your Eye Health - Dry Eye | https://opto.ca/health-library/dry-eye - Accessed April 2018 The Ocular Surface -Visual acuity and quality of life in dry eye disease: Proceedings of the OCEAN group meeting http://www.theocularsurfacejournal.com/article/S1542-0124(16)30234-8/ fulltext - Accessed April 2018

iii Source: Canadian Ophthalmological Society - Dry Eyes http://www.cos-sco.ca/vision-health-information/conditions-disorders-treatments/corneal-diseases/dry-eyes/ - Accessed April 2018 Source: Statistics Canada - Canada at a Glance 2017 - Population | http://www.statcan.gc.ca/pub/12-581-x/2017000/pop-eng.htm - Accessed April 2018

iv Source: Canadian Association of Optometrists - Canadian Journal of Optometry (CJO) Supplement - Dry Eye Disease Guidelines https://opto.ca/sites/default/files/resources/documents/cjo_dry_eye_supplement_2014.pdf - Accessed April 2018

v Source: Statistics Canada - Canada at a Glance 2017 - Population | http://www.statcan.gc.ca/pub/12-581-x/2017000/pop-eng.htm - Accessed April 2018 vi Source: Canadian Ophthalmological Society - Dry Eyes http://www.cos-sco.ca/vision-health-information/conditions-disorders-treatments/corneal-diseases/dry-eyes/ - Accessed April 2018

vii Source: Canadian Association of Optometrists - Your Eye Health - Dry Eye | https://opto.ca/health-library/dry-eye - Accessed April 2018

viii Sources: The Ocular Surface -Visual acuity and quality of life in dry eye disease: Proceedings of the OCEAN group meeting http://www.theocularsurfacejournal.com/article/ S1542-0124(16)30234-8/fulltext - Accessed April 2018 NCBI NLM National Institutes of Health - Dry Eye Disease: Impact on Quality of Life and Vision - Miki Uchino, MD, PhD and Debra A. Schaumberg, Sc.D, O.D., MPH https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3660735/ - Accessed April 2018

ix Source: IQVIA CDH & Compuscript MAT January 2018 x Source: IQVIA CDH & Compuscript MAT January 2018

IR Contacts: United States, Kevin C. Mannix, (215) 591-8912; Ran Meir, (215) 591-3033; Israel, Tomer Amitai, 972 (3) 926 7656; PR Contacts: United States, Elizabeth DeLuca, (267) 468-4329; Israel, Yonatan Beker, 972 (54) 888 5898

SOURCE Teva Canada Limited